MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068503000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Pain (1994); Urinary Retention (2119); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: (b)(6).This event was reported by the patient's legal representation.The surgeon is: dr.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that lynx suprapubic mid-urethral sling system device was implanted into the patient during robotic-assisted total laparoscopic hysterectomy with bilateral salpingo-oophorectomy with cystoscopy, uterosacral ligament suspension, cystotomy with repair, tension-free mid urethral sling retropubic approach, lysis of adhesions procedures performed on (b)(6) 2019 for the treatment of endometriosis, abnormal uterine bleeding, pelvic pain, dyspareunia, urinary urgency, stress incontinence, uti and prolapse of anterior vaginal wall.Postoperatively, the patient experienced pain and pressure from the urinary catheter and bladder spasms which were treated with oxycodone, motrin, and bentyl.On (b)(6) 2020, the patient presented with lower back pain and left upper leg pain with pulling sensation, abdominal pain, problems with bowel movements and urinary retention.It has been going on since the placement for about a year.Patient denies any prolapse but feels like there might be some tugging within the abdomen or pelvis causing some of her pain.The patient stated the pain is getting worse over the last couple of months and has not been able to come in to the office especially with the covid status.She did have an ultrasound performed for post void residual which showed a residual of 33 and it did seem like she was completely emptying.Exam findings included some tension noted throughout the paraspinal muscles with mild tenderness throughout and some decreased range of motion, some abdominal tenderness with deep palpation, mild tenderness of the vaginal cuff.The patient would like to have somewhat of a reversed surgery previously did for prolapse if at all possible.The assessment noted in the medical records at this time included: pelvic pain, urinary retention, generalized abdominal pain, left-sided lumbago with sciatica, and other chronic pain.The physician discussed with the patient the ability to release the uterosacral ligament suspension that was performed and resuture that a little bit lower on the uterosacral ligaments and releasing the sling underneath the urethra to help with some of the blockage sensation she feels with urinating.It was noted that there are other symptoms especially musculoskeletal symptoms causing some of her abdominal pain and back pain, and a ct scan and physical therapy were recommended.Patient wanted to have the surgery first.The patient was also advised that scar tissue could possibly causing the pain.The patient took medication of macrobid 100 mg capsule, twice daily by mouth for seven days.On (b)(6) 2020, the patient underwent release of mid urethral sling and release of uterosacral ligament suspension.Findings during the procedure revealed that there were extensive adhesions noted around the bowel and omentum.Adhesions noted from the vagina to the uterosacral ligaments with prolene sutures in place.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12865643
• MDR Text Key: 284011436
• Report Number: 3005099803-2021-05964
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0022759888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White